Senior Quality Specialist — GMP, Validation & Compliance

Jobgether; San Diego (CA); Hybrid; USD 95,000 - 124,000; Full time

Benefits offered by this job

Stock options

Hybrid work environment

Health & wellness benefits

Onsite collaboration in San Diego

Job summary

Jobgether connects candidates with a partner biotech company in the United States seeking a Senior Quality Specialist, Technical based in the United States. The role supports quality assurance activities across solid oral dose and biologic product programs to ensure regulatory and quality requirements are met.

You will review qualification and validation activities, manage quality workflows, and help maintain data integrity while collaborating with internal teams and external manufacturers.

Qualifications

• Bachelor's degree in life sciences or related field.
• 5+ years of quality experience in biotech/pharma.
• Experience with GMP, CFR/ICH guidelines.
• Strong technical writing and communication.
• Experience with qualification and validation of processes/test methods.

Responsibilities

• Review qualification and validation documents per workflows.
• Assess manufacturing and analytical method validation reports.
• Support change controls and CAPA activities.
• Review investigations and effectiveness checks.
• Ensure data integrity and regulatory readiness.
• Collaborate with cross-functional teams and vendors.
• Travel ~10% domestically/internationally.

Skills

GMP Quality Assurance

Quality documentation

Cross-functional collaboration

Analytical thinking

Regulatory understanding

Education

Bachelor's degree in life sciences or related

Tools

Veeva QMS

eQMS familiarity

Job description

Jobgether connects candidates with a partner biotech company in the United States seeking a Senior Quality Specialist, Technical based in the United States. The role supports quality assurance activities across solid oral dose and biologic product programs to ensure regulatory and quality requirements are met.

You will review qualification and validation activities, manage quality workflows, and help maintain data integrity while collaborating with internal teams and external manufacturers.